Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic and Primary Efficacy of PM1003 in Patients With Advanced Solid Tumors and Phase IIa Study to Evaluate the Primary Efficacy of PM1003 in Advanced Solid Tumors

Biotheus Inc.2 sites in 1 country285 target enrollmentSeptember 7, 2021

ConditionsAdvanced Solid Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumors
Sponsor: Biotheus Inc.
Enrollment: 285
Locations: 2
Primary Endpoint: Dose Limited Toxicity（DLT）
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.

Detailed Description

PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.

Registry

clinicaltrials.gov

Start Date

September 7, 2021

End Date

November 15, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotheus Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
•Male or female aged 18 to 75 years;
•Subjects with malignant tumor confirmed by histology or cytology;
•Adequate organ function;
•ECOG score was 0-
•Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication;
•Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period.

Exclusion Criteria

•History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study;
•Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist;
•Current active infection requiring intravenous anti-infective therapy;
•Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
•Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
•History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.;
•Anticipated need for any other form of antineoplastic drug treatment during the trial;
•Women who are pregnant or breastfeeding;
•Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Outcomes

Primary Outcomes

Dose Limited Toxicity（DLT）

Time Frame: up to 21 days

Occurrence of DLT after receiving PM1003 injection

Assess the incidence and severity of treatment-related adverse events

Time Frame: Up to 30 days after last treatment

The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0